What you need to know about oncology biosimilars now

With more than 1.9 million new cancer cases projected to be diagnosed in 2020, Amgen's recent launches of its ?rst two therapeutic oncology biosimilars in the United States have the potential to o?er patients and the healthcare system more affordable biosimilar treatment option alternatives to the originator biologic medicines. 1,2,3

Biosimilars may help generate signi?cant savings to the healthcare system.4 Some estimates from Rand Health Quarterly and IQVIA project cost savings in the next 5 to 10 years of approximately $150 billion.4,5 An increasingly competitive marketplace that includes biosimilars lends credence to these projections. Case in point: 2019 was a remarkably productive year for biosimilars; FDA approved a record-setting 10 biosimilars – bringing the total to 26 approved biosimilars to 9 reference products. Currently, 15 out of 26 FDA-approved biosimilars are indicated for oncology, 13 of which (7 therapeutic oncology products; 6 supportive care products) are currently available on the U.S. market.2,6,7,8,9,10,11,12,13,14,15These biosimilars span a diverse array of indications, treating patients with acute myeloid leukemia, metastatic carcinoma of the colon or rectum, and metastatic breast cancer, among other conditions.6

At Amgen, we are striving to reduce the burden of cancer and reach for cures. As such, we understand both the critical value of continued innovation to address unmet needs, and the need for increased availability of high-quality biosimilars to potentially improve patient access to existing therapies.16 We’re proud to be developing innovative medicines for novel targets in di?icult-to-treat cancers, while also delivering biosimilars of important existing oncology medicines.17 Building on our heritage of innovation, we have made and continue to make signi?cant investments in our biosimilars portfolio, recently launching two therapeutic oncology biosimilars in the U.S. market (including the ?rst therapeutic oncology biosimilar approved by the FDA), and look forward to developing and bringing more oncology biosimilars to market.2 We fully expect our oncology biosimilars to provide immediate cost savings for Medicare patients and commercial payers.

A recent SERMO survey conducted by Amgen among oncologists, gastroenterologists, rheumatologists, and other specialties assessed physicians’ confidence in prescribing biosimilars and identified the most influential criteria for selecting biosimilars for their patients. Nearly 40 percent of physician respondents noted that the biggest barrier to prescribing biosimilars are concerns about the quality of products or reliability of supply. Approximately 25 percent of respondents indicated that the most influential criteria when selecting which biosimilar product to use is either robustness or totality of evidence data, or cost of contract.18

With those results in mind, science-based education around a few key points can continue to help build the con?dence among patients and physicians that they can, and should, trust biosimilars as a part of their oncology care plan.

• Biosimilars Meet FDA's Safety and Efficacy Standard for Approval: U.S. law de?nes a biosimilar as a biologic that is highly similar to, and has no clinically meaningful di?erences from, its biologic reference product.19 This means patients and physicians can have confidence that a biosimilar’s safety and e?icacy meet FDA’s stringent regulatory approval standards.
• Biosimilars Are Approved Based on Rigorous, Science-Based Standards: Scienti?cally appropriate regulatory standards that follow International Conference on Harmonization (ICH) guidelines are required to ensure that biological products, including biosimilars, meet an appropriate standard of safety and efficacy.18 The goal of a biosimilar development program is not to independently re-establish safety and e?icacy comparable to that of the reference product, but rather, to demonstrate that the proposed biologic product is biosimilar to the reference product. Regulators like FDA and the European Medicines Agency (EMA) review the totality of the evidence, including comparative analytical and clinical studies, when evaluating biosimilarity.20
• Good Manufacturing Practices (GMP) Standards Apply to All Biological Products, including Biosimilars 21: The application of rigorous quality standards is imperative to support the safety and e?icacy of originator biologic medicines and biosimilars, and to instill stakeholder con?dence in their use. In addition to biosimilars meeting manufacturing and quality requirements applicable to all biologics, Amgen commits the same scientists, manufacturing capabilities, and commercial infrastructure and support to bring high-quality, reliably supplied originator biologics and biosimilar medicines to market.
• Patients Must be Empowered to Learn About Biosimilars: Biosimilars can provide a potentially more cost-e?ective treatment option.5 For patients, that understanding begins with dialogue around what biosimilars are; how they are manufactured and developed; and how they are approved by regulators. Over time, this knowledge will build collective understanding and con?dence in their use.

In conclusion, biosimilars have the potential to deliver additional treatment options to patients at reduced cost while simultaneously contributing to a more sustainable healthcare system.4,5 These bene?ts are something that we all can, and should, get behind.

For more information about biosimilars, visit www.AmgenBiosimilars.com.

REFERENCES

1. “CDC - Expected New Cancer Cases and Deaths in 2020.” Centers for Disease Control and Prevention, Centers for Disease Control and Prevention. Projected new cancer cases graphic. August 16, 2018. URL: https://www.cdc.gov/cancer/dcpc/research/articles/cancer_2020.htm. Accessed January 2020. (Note, graph shows that the number of new cancer cases is expected to increase from about 1.5 million per year in 2010 to 1.9 million per year in 2020).

2. Amgen. Press release. July 18, 2019. Accessed January 2020.

3. Patel KB, Arantes LH Jr, Tang WY, Fung S The role of biosimilars in value-based oncology care. Cancer Manag Res. 2018; 10: 4591-4602. doi: 10.2147/CMAR.S164201.

4. IQVIA Institute for Human Data Science. The Global Use of Medicine in 2019 and Outlook to 2023. January 29, 2019. URL: https://www.iqvia.com/institute/reports/the-global-use-of-medicine-in-2019-and-outlook-to-2023. Accessed January 2020.

5. Mulcahy, AW, Hlavka, JP, Case, SR. Biosimilar cost savings in the United States: initial experience and future potential. URL: https://www.rand.org/pubs/perspectives/PE264.html. Accessed January 2020.

6. U.S. Food and Drug Administration. Biosimilar Product Information. December 2019. URL: https://www.fda.gov/drugs/biosimilars/biosimilar-product-information. Accessed January 2020.

7. Sandoz. Press release: Sandoz launches Zarxio? (?lgrastim-sndz), the ?rst biosimilar in the United States. September 3, 2015. URL: https://www.sandoz.com/news/media-releases/sandoz-launches-zarxiotm-?lgrastim-sndz-?rst-biosimilar-united-states. Accessed January 2020.

8. The Center for Biosimilars. Mylan Con?rms That It Has Launched Fulphila in the United States. July 30, 2018. URL: https://www.centerforbiosimilars.com/news/mylan-con?rms-that-it-has-launched-fulphila-in-the-united-states. Accessed January 2020.

9. The Center for Biosimilars. P?zer Launches Biosimilar Filgrastim, Nivestym, at a Substantial Discount. October 3, 2018. URL: https://www.centerforbiosimilars.com/news/p?zer-launches-biosimilar-?lgrastim-nivestym-at-a-substantial-discount. Accessed January 2020.

10. Big Molecule Watch. P?zer Launches RETACRIT (Epoetin Alfa-epbx) Biosimilar in United States. November 14, 2018. URL: https://www.bigmoleculewatch.com/2018/11/14/p?zer-launches-retacrit-epoetin-alfa-epbx-biosimilar-in-united-states/. Accessed January 2020.

11. The Center for Biosimilars. Coherus Con?rms That It Has Launched Its Peg?lgrastim Biosimilar, Udenyca. January 4, 2019. URL: https://www.centerforbiosimilars.com/news/coherus-con?rms-that-it-has-launched-its-peg?lgrastim-biosimilar-udenyca. Accessed January 2020.

12. Teva. Press release: Teva and Celltrion Announce the Availability of TRUXIMA? (rituximab-abbs) Injection, the First Biosimilar to Rituxan? (rituximab) in the United States. November 7, 2019. URL: https://ir.tevapharm.com/investors/press-releases/press-release-details/2019/Teva-and-Celltrion-Announce-the-Availability-of-TRUXIMA-rituximab-abbs-Injection-the-First-Biosimilar-to-Rituxan-rituximab-in-the-United-States/default.aspx. Accessed January 2020.

13. The Center for Biosimilars. Novartis Confirms It Has Launched Biosimilar Pegfilgrastim, Ziextenzo, in the United States. November 15, 2019. URL: https://www.centerforbiosimilars.com/news/novartis-confirms-it-has-launched-biosimilar-pegfilgrastim-ziextenzo-in-the-united-states. Accessed February 2020.

14. The Center for Biosimilars. Mylan and Biocon Launch Biosimilar Trastuzumab, Ogivri, in the United States. December 2, 2019. URL: https://www.centerforbiosimilars.com/news/mylan-and-biocon-launch-biosimilar-trastuzumab-ogivri-in-the-united-states. Accessed February 2020.

15. Pfizer. Company statement. Pfizer Brings Three New Biosimilars to U.S. Patients at Substantial Discounts. January 23, 2020. URL: https://pfe-pfizercom-prod.s3.amazonaws.com/news/U.S.%20mAb%20Launch%20Press%20Statement.pdf. Accessed February 2020.

16. IQVIA. 2018. The Impact of Biosimilar Competition in Europe. PDF file. Retrieved from: https://www.medicinesforeurope.com/wp-content/uploads/2017/05/IMS-Biosimilar-2017_V9.pdf. Accessed January 2020.

17. Amgen. Our Pipeline. URL: https://www.amgenbiosimilars.com/products/our-pipeline/. Accessed January 2020.

18. SERMO Physician Survey. “What you need to know about oncology biosimilars now?” Amgen Data on File. December 2019.

19. Biologics Price Competition and Innovation Act of 2009. 42 USC § 262.

20. International Conference on Harmonization. Quality Guidelines. URL: https://www.ich.org/products/guidelines/quality/article/quality-guidelines.html. Accessed January 2020.

21. U.S. Food and Drug Administration. Guidance for Industry and FDA Sta?: Current Good Manufacturing Practice Requirements for Combination Products. January 2017. URL: https://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM429304.pdf. Accessed January 2020.